Group Medical Director, Clinical Development - Oncology

Role Summary

Group Medical Director, Clinical Development - Oncology. Leads design, execution, and interpretation of clinical trials within one or more clinical development programs, aligning with product development plans and regulatory requirements.

Responsibilities

• Personally or through a direct report, lead the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan; oversee education of investigators and study site personnel.
• Provide leadership and mentoring for clinical study teams; ensure study integrity, safety and efficacy data interpretation, and timely delivery of key study milestones.
• Own the design, analysis, interpretation, and reporting of scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, and other program documents.
• Manage one level of Medical and Scientific Directors and/or Clinical Scientists; hire, onboard, mentor, train, and support career development of team members.
• May chair Clinical Strategy Teams; develop a cross-functionally aligned Clinical Development Plan; supervise matrix team members and support Asset Development Teams and Leadership Boards.
• Serve as in-house clinical expert for one or more molecules/diseases; coordinate scientific activities with internal stakeholders; contribute to due diligence and translational strategies as needed.
• Lead clinical interactions with opinion leaders; collaborate with Medical Affairs, Commercial, and other functions to incorporate broad cross-functional perspectives into Clinical Development Plans.
• Stay current with professional information and participate in external meetings as appropriate.
• Ensure understanding and compliance with regulatory requirements for clinical studies and global drug development; act as clinical representative in regulatory discussions.
• Ensure adherence to Good Clinical Practices, pharmacovigilance standards, SOPs, and other quality standards in research conduct.

Qualifications

• Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent with relevant therapeutic specialty; residency strongly preferred; subspecialty fellowship desirable.
• At least 7 years (9+ preferred) of clinical trial experience in pharma, academia, or equivalent.
• Ability to run a complex clinical research program independently.
• Proven leadership skills; ability to lead and influence cross-functional global teams.
• Commitment to training and developing junior staff with appropriate autonomy.
• Ability to interact externally and internally to support global scientific and business strategy.
• Extensive knowledge of clinical trial methodology, regulatory/compliance requirements, and experience in clinical strategy and protocol design.
• Excellent oral and written English communication skills.
• Ability to address complex problems and create solutions across multiple projects.

Skills

• Clinical trial design and execution
• Regulatory affairs and compliance
• Data interpretation and scientific communication
• People management and mentorship
• Cross-functional collaboration

Education

• Medical degree (M.D. or D.O.) or equivalent